Class Class II
BioBrace® Reinforced Implant (K241906)
Description
BioBrace® Reinforced Implant by Conmed Corporation, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241906
Clearance Date2024-07-29
Clearance TypeSpecial
Product CodeOWW
Regulation Number878.3300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241906
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BioBrace® Reinforced Implant (K241906) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203267 | The BioBrace Implant | Biorez, Inc. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250395 | BioBrace ® RC Delivery System | Conmed Corporation | 2025 |
| K242187 | BioBrace® | Conmed Corporation | 2024 |
Trace the full predicate network for K241906
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.